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Awarded Trial: 14T-012
Grant ID
14T-012
Illness
Bipolar disorder
Primary Drug/Intervention
Trehalose
Primary Dosage
2 g
Secondary Drug Intervention
Saccarose
Secondary Dosage
2g
Other Drug/Intervention
Lithium
Other Dosage
0.5-1.2 mmol/L
Status
Completed
Investigator
Vieta
Sample Size
60
Duration of Study Period for Each Subject
42 days
Outcome Measurements
1) Severity of depressive symptoms as measured by MADRS 2) CGI-BP severity of depression and mania 3) Patient functioning and well-being measured by FAST and the WHO well-being index
Results
Trehalose is a disaccharide which protects cells from hypoxic and anoxic injury, and suppresses protein aggregation. Studies with trehalose on animal models of neurodegenerative diseases show cellular and behavioral beneficial effects. Trehalose enhances autophagy, a process that had been suggested to be involved in the therapeutic action of antidepressant and mood-stabilizing drugs, and may augment the effects of lithium. Dr. Vieta performed a RCT of adjunctive Trehalose added on to lithium in bipolar depression. 17 patients with bipolar depression receiving lithium, were randomized to 6 weeks double-blind with trehalose 2g/d, or placebo. Nine were allocated to trehalose and 8 to placebo, 11 completed the study. The change in the median of the MADRS depression scale from 6 week end-of-study to baseline visit in the trehalose group was -5.1 (SD 5.6) and in the placebo group was -8.3 (SD 5.7), p=NS. This study did not demonstrate Trehalose as an effective add-on treatment for bipolar depression.
Publication
N/A
Link
N/A
PI Name
Eduard Vieta
Degree
MD, PhD
Center
Hospital Clinic de Barcelona
Institution
Centro de Investigacion Biomedica en Red (CIBER)
Address
Villarroel 170
City or Town
Barcelona
State or Province
Catalunya
Zip or Postal Code
08025
Country
Spain
Email Address
evieta@clinic.ub.es